REFINED SESAME OIL IV-1

Description

Refined Sesame Oil IV-1 is obtained from the seeds of one or more varieties of Sesamun indicum L. (Fam. Pedaliaceae) by expression followed by a refining process. Refined Sesame Oil IV-1 complies with the specifications of European Pharmacopoeia monograph “Sesame Oil, refined” <0433> and NF/US Pharmacopeia monograph “Sesame Oil”, intended for use in the manufacture of parenteral preparations. Strict selection, based on starting materials and product analysis, allows deliveries of homogen batches, in accordance with the Pharmaceutical GMP requirements. Supported with Drug Master File (DMF type IV, # 031 697) for excipients submitted to the U.S. Food and Drug Administration (FDA).

HIGH STABILITY GUARANTEE

Stability studies performed according to the International Conference on Harmonization (ICH) Q1A Quality Guideline show that Refined Sesame Oil IV-1 is perfectly stable over a 36-month shelf life period.

PACKAGING

ADM-SIO’s Refined Sesame Oil IV-1 is available in 56,5 Kg or 200 Kg tight-head metal drums that are filled under nitrogen in an ISO 8-classified cleanroom.